🔍 RecallPedia

Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Approx. Osmolarity 386 mOsm/L, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1

Class I - Dangerous
💊 Drugs Recalled: July 14, 2023 Central Admixture Pharmacy Services Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: 36-252365, 36-252368, 36-252369, 36-253887, 36-253888, Exp. 8/1/2023; 36-254404, 36-254406, 36-254407, 36-254408, 36-254409, 36-254410, Exp. 8/5/2023; 36-255219, 36-255220, 36-255221, 36-255222, 36-255223, Exp. 8/7/2023; 36-255420, 36-255421, 36-255422, 36-255424, 36-255425, 36-255453, 36-255454, 36-255731, Exp. 8/8/2023; 36-247605, 36-247608, 36-247609, 36-247610, Exp. 7/10/2023; 36-255880, 36-255881, 36-255882, 36-255883, 36-255884, 36-255885, 36-255887, 36-256004, Exp. 8/11/2023; 36-247819, 36-247820, 36-247821, 36-247822, Exp. 7/11/2023; 36-256108, 36-256109, 36-256110, 36-256111, 36-256112, 36-256113, Exp. 8/12/2023; 36-248139, 36-248142, 36-248143, 36-248144, Exp. 7/12/2023; 36-256326, 36-256327, 36-256328, 36-256329, 36-256330, 36-256331, Exp 8/13/2023; 36-256701, 36-257025, Exp. 8/14/2023; 36-248303, 36-248304, 36-248305, 36-248306, 36-248316, Exp. 7/14/2023; 36-248509, 36-248511, 36-248513, 36-248514, Exp. 7/15/2023; 36-248815, 36-248816, 36-248817, 36-248818, Exp. 7/16/2023; 36-248962, 36-248964, 36-248966, Exp. 7/17/2023; 36-249216, 36-249220, 36-249222, Exp. 7/18/2023; 36-249575, 36-249576, 36-249577, Exp. 7/19/2023; 36-249631, 36-249632, Exp. 7/21/2023; 36-249836, Exp. 7/22/2023; 36-250033, 36-250034, 36-250035, Exp. 7/23/2023; 36-250388, 36-250391, Exp. 7/24/2023; 36-251697, 36-251699, 36-251700, Exp. 7/30/2023; 36-252078, 36-252079, 36-252080, Exp. 7/31/2023.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Central Admixture Pharmacy Services, Inc.
Reason for Recall:
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Approx. Osmolarity 386 mOsm/L, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1

Product Codes/Lot Numbers:

Lot: 36-252365, 36-252368, 36-252369, 36-253887, 36-253888, Exp. 8/1/2023; 36-254404, 36-254406, 36-254407, 36-254408, 36-254409, 36-254410, Exp. 8/5/2023; 36-255219, 36-255220, 36-255221, 36-255222, 36-255223, Exp. 8/7/2023; 36-255420, 36-255421, 36-255422, 36-255424, 36-255425, 36-255453, 36-255454, 36-255731, Exp. 8/8/2023; 36-247605, 36-247608, 36-247609, 36-247610, Exp. 7/10/2023; 36-255880, 36-255881, 36-255882, 36-255883, 36-255884, 36-255885, 36-255887, 36-256004, Exp. 8/11/2023; 36-247819, 36-247820, 36-247821, 36-247822, Exp. 7/11/2023; 36-256108, 36-256109, 36-256110, 36-256111, 36-256112, 36-256113, Exp. 8/12/2023; 36-248139, 36-248142, 36-248143, 36-248144, Exp. 7/12/2023; 36-256326, 36-256327, 36-256328, 36-256329, 36-256330, 36-256331, Exp 8/13/2023; 36-256701, 36-257025, Exp. 8/14/2023; 36-248303, 36-248304, 36-248305, 36-248306, 36-248316, Exp. 7/14/2023; 36-248509, 36-248511, 36-248513, 36-248514, Exp. 7/15/2023; 36-248815, 36-248816, 36-248817, 36-248818, Exp. 7/16/2023; 36-248962, 36-248964, 36-248966, Exp. 7/17/2023; 36-249216, 36-249220, 36-249222, Exp. 7/18/2023; 36-249575, 36-249576, 36-249577, Exp. 7/19/2023; 36-249631, 36-249632, Exp. 7/21/2023; 36-249836, Exp. 7/22/2023; 36-250033, 36-250034, 36-250035, Exp. 7/23/2023; 36-250388, 36-250391, Exp. 7/24/2023; 36-251697, 36-251699, 36-251700, Exp. 7/30/2023; 36-252078, 36-252079, 36-252080, Exp. 7/31/2023.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0956-2023

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